Evaluation of a sex education lesson on chlamydia to see whether it increases the likelihood that young adults will use condoms to protect against this sexually transmitted infection (STI)

ISRCTN ISRCTN54091015
DOI https://doi.org/10.1186/ISRCTN54091015
Secondary identifying numbers N/A
Submission date
22/11/2012
Registration date
28/12/2012
Last edited
14/12/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Young people may underestimate their risk of getting a sexually transmitted infection (STI) called chlamydia. This infection can be serious if untreated, leading to conditions such as infertility. Increasing young peoples' knowledge and understanding of this STI may increase their motivation to use condoms to protect themselves against it. The study aims to find out if after having a sex education lesson on chlamydia, young peoples' beliefs about the risk of chalmydia have changed and whether they are then more likely to use condoms during sexual intercourse.

Who can participate?
Pupils aged 13-16 from selected secondary schools across England

What does the study involve?
Schools are selected at random to give either just their usual teaching on STIs, or their usual teaching on STIs plus a specially designed lesson on chlamydia. All pupils are asked to complete three short questionnaires: one before the lessons, one straight after, and one three months later.

What are the possible benefits and risks of participating?
Pupils get the opportunity to be involved in shaping future sex education on STIs. Schools receive a £60 Amazon voucher in recognition of the time and support they have given to the study. There are not thought to be any risks involved with taking part.

Where is the study run from?
Coventry University (Applied research Centre in Heath and Lifestyle Interventions (ARC-HLI)) and the Health Protection Agency (Primary Care Unit) are running this study. Coventry University is the lead organisation.

When is the study starting and how long is it expected to run for?
January 2013 to December 2013

Who is funding the study?
The study has no funding. Researchers' time and overheads are being funded by their respective organisations.

Who is the main contact?
Katie Newby
k.newby@coventry.ac.uk

Contact information

Mrs Katie Newby
Scientific

Coventry University
Faculty of Health and Life Sciences
ARC-HLI / WF121
Priory Street
Coventry
CV1 5FB
United Kingdom

Email k.newby@coventry.ac.uk

Study information

Study designTwo-arm cluster randomised controlled trial with a waiting-list control
Primary study designInterventional
Secondary study designCluster randomised trial
Study setting(s)School
Study typePrevention
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleIncreasing young adults' condom use intentions and behaviour through changing chlamydia risk and coping appraisals: a cluster randomised controlled trial of efficacy
Study objectivesPrimary research question
1. Is the lesson effective in increasing young people's intentions to use condoms during vaginal sex with casual sexual partners?

Secondary research questions
2. Is the lesson effective in increasing young people's condom use during vaginal sex with casual sexual partners?
3. If the lesson is effective, are changes in young people's condom use intentions or behaviour due to changes in their chlamydia risk appraisals (perceived likelihood and severity) and/or coping appraisals (condom use response efficacy and self-efficacy)?
Ethics approval(s)Coventry University Ethics Committee - approval pending
Health condition(s) or problem(s) studiedChlamydia trachomatis
InterventionIn the experimental group, participants will receive the school's standard teaching on STIs plus a theory- and evidence-based lesson on chlamydia.

In the control group participants will receive just their school's usual teaching on STIs.

The teaching will last 40 minutes. The duration of follow-up is three months.
Intervention typeBehavioural
Primary outcome measureIntention to use condoms during vaginal sex with casual sexual partners over the next three months
Secondary outcome measures1. Use of condoms during vaginal sex with casual sexual partners over three months post delivery
2. Perceived likelihood of chlamydia
3. Perceived severity of chlamydia
4. Response efficacy for condom use
5. Self-efficacy for using condoms during vaginal sex with casual sexual partners over the next three months
Overall study start date01/01/2013
Completion date31/12/2013

Eligibility

Participant type(s)Other
Age groupChild
Lower age limit13 Years
Upper age limit16 Years
SexBoth
Target number of participants770
Key inclusion criteria1. Aged 13-16 years old
2. Attending a secondary school in England which has a Sex and Relationships Education (SRE) protocol and curriculum
3. Have not received any previous formal education on STIs through school
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment01/01/2013
Date of final enrolment01/03/2013

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Coventry University
Coventry
CV1 5FB
United Kingdom

Sponsor information

Coventry University (UK)
University/education

Priory Street
Coventry
CV1 5FB
England
United Kingdom

Phone +44 (0)24 7688 7688
Email genenq.hls@coventry.ac.uk
Website http://www.coventry.ac.uk
ROR logo "ROR" https://ror.org/01tgmhj36

Funders

Funder type

University/education

Coventry University (UK)
Private sector organisation / Universities (academic only)
Alternative name(s)
CU
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 30/05/2013 Yes No

Editorial Notes

14/12/2017: Publication reference added.